Apparatus for obtaining urine samples



April 14, 1970 J. D. GIESY APPARATUS FOR OBTAINING URINE SAMPLESOriginal Filed Aug. 28, 1964 JerP D 312 6 SH United States Patent 26,854APPARATUS FOR OBTAINING URINE SAMPLES Jerry D. Giesy, 8335 SW. RidgewayDrive, Portland, Oreg. 97225 Original No. 3,335,714, dated Aug. 15,1967, Ser. No. 392,745, Aug. 28, 1964. Application for reissue July 15,1969, Ser. No. 848,370

Int. Cl. A6111 5/00; Afilf 5/44; A61g 9/00 US. Cl. l282 5 Claims Matterenclosed in heavy brackets appears in the original patent but forms nopart of this reissue specification; matter printed in italics indicatesthe additions made by reissue.

ABSTRACT OF THE DISCLOSURE An apparatus for collecting uncontaminatedwine samples from female patients includes a container with an elongatedtube sealingly mounted in the open end of the container. The tube on itsdistal end includes a compressible and resilient pad portion which isadapted to be poistioned to produce close encirclement of the urethralmleatus' to form a seal thereabout and provide urine samples free fromextraurethral contamination.

This invention relates to collecting urine samples from female patients,where special problems are introduced in obtaining urine samples freefrom extraurethral contamination.

Medical science has become increasingly aware of the importance ofobtaining urine samples in performing a thorough examination of apatient. It has been discovered, for instance, that in the vast majorityof cases, urine samples collected from patients either show very fewbacteria, or a bacteria count which is many times what is usual. A lowbacteria count is indicative of a normal condition, while a highbacteria count often indicates an unhealthy condition which suitablediagnosis may correct. A bacteria count falling between these low andhigh ranges is a relatively rare event. Thus, in order that urineanalysis be a useful diagnostic tool for the physician, it is importantthat a means be devised that makes possible the taking of urine sampleswhere the bacteria therein is an accurate reflection of the condition ofthe urine as it exists in the bladder.

In the female, because of the position of the urethra, ditficulties havebeen encountered in obtaining truly representative urine samples.Commonly, such samples are obtained by inserting a catheter into theurethra, with urine then flowing directly from the bladder. This,however, has the potential danger of introducing bacteria into whatpreviously was a sterile bladder, a particularly disadvantageous featurewith patients susceptible to urinary tract infections. With othertechniques, urine samples frequently are contaminated with bacteriaderived from extraurethral sources, such as the vagina, so that thesamples do not show the condition of the urine as it exists in thebladder.

Generally, an object of the invention is to provide a device forobtaining urine samples from the urethra, where such samples arecollected without penetration of the urethra and are relatively free ofextraurethral contamination.

More specifically, an object is to produce such a device which includesmeans that forms a relatively tight seal about the meatus of theurethra, such seal defining a zone which excludes regions outside theurethra from where extraurethral contamination might be derived.

Yet a further object is to provide a device for taking urine sampleswhich may be placed simply and rapidly Re. 26,854 Reissued Apr. 14, 1970"ice in operative, urine-collecting position. The device features meanswhich senses the anterior vaginal wall and with reference to this wallproperly positions the sealing means described. The device isparticularly well adapted to be used with the patient in a sittingposition.

Yet another object is to provide a novel method for obtaining urinesamples from females, which relies upon establishing a sealed zone aboutthe meatus of the urethra, with such zone being properly positioned byreference to the anterior vaginal wall but excluding the vagina properand adjoining areas.

These and other objects and advantages are obtained by the invention,and the same is described in connection with the accompanying drawings,wherein:

FIG. 1 illustrates apparatus as contemplated herein, with portionsbroken away, such including a tubular body and a container forcollecting urine mounted on one end of the tubular body;

FIG. 2 is a top view of the apparatus in FIG. 1;

FIG. 3 is a cross sectional view, taken along the line 3-3 in FIG. 2;and

FIG. 4 illustrates in dashed outline a representative female pelvis inmedian section, and shows how the device is used to obtain urinesamples.

Referring now to the drawings, it will be noted that the apparatusillustrated comprises an elongated tubular body 10, comprising tube 12,and mounted on an end 12a of this tube, an annular pad indicated at 14.

Tube 12 preferably is made of a rigid or semirigid material, such asPyrex, to enable suitable positioning of end 12a thereof by manipulationof ends 12b. Pad 14 may be of compressible and resilient relatively softmaterial, whereby a cushion is formed at one end of the tubular body,and by way of example may be made of foamed rubber or other elastomer.

Extending along through the tube is a channel 16. Pad 14 has a centeropening extending therethrough, shown at 18, and opening 18 and channel16 together form a passage extending the length of the tubular body withan entrance end adjacent end 12a of tube 12.

It will be noted that tube 12 is bent at 20 between the ends thereof, sothat tubular body 10 has a concave-convex outline viewing a side profilethereof. Thus, two reaches of tube are present which extend out toopposite ends of the tube and which define an obtuse angle, shown at A.This angle in a typical case may be in the range of plus or minus 5.

The upper end of the tubular body in FIG. 1, i.e., end 12a of the tubeand pad 14, is placed between the labia of a female when taking a urinesample, and to facilitate such positioning, end 12a of tube 12 may beflattened slightly, as best shown in FIG. 2, whereby a somewhatelliptical outline is given to the cross section thereof. This outlineis shared by cushion or pad 14.

At end 12a of tube 12, opposite lateral sides of the tube are shownbounded by concave edges such as the one indicated at 24. Pad 14 isgrooved at 26 on the underside thereof and this groove receives theedges bounding the end of the tube including edges 24.

As best shown in FIGS. 2 and 3, pad 14 includes a shoulder 28 locatedbeyond end 12a of the tube and supported by a wall 29 adjacent one sideof tube 12. A surface 30 bounds shoulder 28 on the inside of theshoulder, and, as best illustrated in FIG. 3 by the angle B, the surfaceslopes away from the axis of passage 12 progressing axially inwardlyfrom the end of the tubular body. Integral with opposite ends ofshoulder 28 are lip portions 32, and these smoothly meet with a heelportion 34, the heel and lip portions also being beyond end 12a of thetube. Wall 29 is flexible, and thus permits shoulder 28 to flexoutwardly (or to the left in FIG. 3) when the device is used. Lipportions 32 joining with the shoulder are stretchable and elongate whenshoulder 28 is bent outwardly. With the pad of compressible, resilientmaterial, they are also compressible to a degree, in an axially inwarddirection at the end of the tubular body.

As best shown in FIG. 1, the outer end of shoulder 28, the lip portions,and the outer part of portion 34 generally define a plane C which isinclined from perpendicularity to the axis of the tube adjacent end 12a.Describing the relationship in another way, the heel portion is disposedinwardly toward end 12a of the tube from a plane passing through theoutermost extremity of the shoulder and normal to the axis of end 1221of the tube.

Further describing the device, lower end 12b of the tube extends througha stopper 48 which is employed to mount the tube in the top of a flaskor container 50, with the passage within tube 12 communicating with theinterior of the flask. At 52 is indicated a vent conduit whichcommunicates with the interior of the flask through the stopper. Adiaphragm 54 forms a dam between the top of the flask and upper portionsof tube 20. Thus, the crevice around the stopper where the stopper meetsthe neck of the flask is covered.

Referring to FIG. 4, where a female pelvis is illustrated in mediansection with such female in a sitting position, bodily portions showninclude a bladder 60, the vagina 62, the symphysis pubis 64, and rectum66. The urethra which connects with the bladder is shown at 68 and theurethral meatus at 68a. The distal end of the anterior wall of thevagina is indicated at 62a, and it will be noted that the anterior wallof the vagina and tissue adjacent the urethral meatus form what isreferred to herein as a vaginal vestibule angle designated at 70.

When using the device of the invention, as an initial step, the deviceis thoroughly sterilized so as to be free of contamination. The patientwhose urine is to be analyzed may then be placed in a seated positionwith her legs spread slightly apart. To obtain a sample, the upper endof the tube with pad 14 thereon is inserted between the labia and thepad brought to bear on tissue surrounding the urethral meatus with thepad thus forming a sealed zone about the meatus. Positioning of the padis accomplished by proper manipulation of the flask and lower portion oftube 12. In positioning the pad, shoulder 28 is utilized as apositioning aid by moving surface 30 of the shoulder against the distalend of the anterior vaginal wall. With the pad positioned so as toencircle the urethral meatus and vestibule angle, the pad is pressedfirmly against the tissue surrounding the meatus so that throughprolapse of the meatus and adjacent tissue a protrusion is formed (shownin FIG. 4 at 72) extending into the space bounded by the pad. The paditself deforms somewhat, with shoulder 28 bending outwardly or to theleft. In FIG. 4 it will be noted that surface 30 more nearly parallelsthe side wall of the tube than it does in FIG. 3. With outward bendingof the shoulder, there is stretching and elongation of lips 32. Sincethe lips are bearing against tissue, they also tend to be compressedinwardly somewhat, and thus in FIG. 4 a concave curvature is illustratedfor the edges of the lips which is not shown in FIG. 3.

Ultimately a snug fit is produced about tissue protrusion 72. Surface 30forms a seal with the anterior wall of the vagina, and the pad lips andportion 34 likewise form a seal with the tissue around the meatus.Because of the angularity described in connection with plane C definedby the top of the pad, tube 12 extends out from the labia at the slightincline illustrated in FIG. 4, thus to clear any means used to supportthe patient in her seated position. With the bend described in the tube,proper drainage into the flask occurs.

It will be noted that there is no penetration of the urethra. Arelatively small sealed region is produced by the pad which includesonly a small portion of the anterior vaginal wall. Urine flowing intothe flask in this manner is kept free from extraurethral contaminationand this is done without incurring the danger of introducing bacteriainto the urethra.

Upon completing the taking of a urine sample, it is an easy matter toremove the device from the patient, and afterwards separate the stopperfrom the flask to accommodate the removal of urine from the flask.

The device of the invention may be utilized as described in taking urinesamples from female patients of widely different ages and physicaldescriptions. Results have indicated that reliable bacteria counts areobtainable using the method.

While there has been described an embodiment of the invention,variations and modifications are possible without departing therefrom.It is desired to cover all such modifications and variations as would beapparent to one skilled in the art, and that come within the scope ofthe appended claims.

It is claimed and desired to secure by Letters Patent:

1. A device for obtaining urine samples from the urethra, with suchsamples free of extraurethral contamination, comprising an elongatedtube of stiff material having a passage extending therethrough wtih anentering end of the passage at one end of the tube,

said tube between the ends thereof containing a bend whereby two reachesare present which define an obtuse angle, one of such reaches extendingout to said one end of the tube,

an annular pad of stretchable and more pliable material than the tubemounted on said one end of the tube and extending around said enteringend of said passage,

said pad including a shoulder on one side of the tube and said one end,which is disposed outwardly beyond said one end of the tube and boundedby an inner surface that slopes away fro-m the axis of said tubeprogressing axially inwardly from said one end,

said pad further including opposed lip means and a heel portion on theside of said tube opposite the tubes said one side which are outwardlybeyond said one end of the tube and cooperate with said shoulder tobound said entering end and to produce encirclement of a urethral meatusand to form a seal thereabout with the device in operative position,

said heel portion being disposed inwardly toward said one end of thetube from a plane passing through the outermost extremity of saidshoulder and normal to the axis of said one end of the tube.

2. A device for obtaining urine samples from the urethra, with suchsamples free of extraurethral contamination, comprising an elongatedtube having a passage extending therethrough with an entrance to saidpassage at one end of the tube,

said tube being of stiff material to enable positioning of said one endby manipulation of the opposite end of the tube,

an annular pad of compressible and resilient material mounted on saidone end of the tube and extending around said entrance of said passage,

said pad including a shoulder on one side of the tube disposed beyondsaid one end of the tube and supported by a flexible wall in said padpermitting said shoulder to deflect laterally of the tube,

said pad further including oppositely disposed lip portions joining withopposite ends of said shoulder, which are disposed outwardly beyond saidone end of the tube and are stretchable to permit elongation, anddeflecting of said shoulder,

said pad further including a heel portion disposed beyond said one endof the tube and on the side of the tube opposite the tubes said one sidewith opposite ends of the heel portion joining with said lip portions,

said lip portions, heel portions, and shoulder cooperating to produceencirclement of a urethral meatus and to form a seal thereabout with thedevice in operative position,

said heel portion being disposed inwardly toward said one end of thetube from a plane passing through the outermost extremity of saidshoulder and normal to the axis of said one end of the tube 3. Thedevice of claim 2 wherein said lip portions, heel portions, and shoulderare adapted by their shape and position to produce close encirclement oithe urethral meatus to form a seal immediately thereabout with thedevice in operative position.

4. A device for obtaining urine from the urethra, said devicecomprising: an elongated relatively stifi tube portion having apassageway extending therethrough with an entrance to said passageway atone end of the tube portion, said tube portion being of such stiffnessas to enable insertiOn and positioning of said one end of the tubeportion within the female user by manipulation of the opposite end ofthe tube portion; and an annular padlike portion of resilient materialon said one end of the tube portion and having an open-ended urinepassage forming a continuation of said entrance of said tube portionpassageway, said pad-like portion including an intermost shoulderadapted by its shape and position to engage the anterior wall of thevagina, said shoulder being part of a flexible wall in said pad-likeportion which permits said shoulder to deflect laterally of the tube,said pad-like portion further including oppositely disposed lip 30sections joining with opposite ends of said shoulder and defining withsaid shoulder part of a urine entryway to said open-ended urine passage,said lip sections being stretchable to permit deflection thereof and ofsaid shoulder, said pad-like portion further including a heel sectionjoining with the end of said lip sections opposite that connected tosaid shoulder, said heel section being disposed inwardly toward said oneend of the tube portion relative to a transverse plane passing throughthe outermost extremity of said shoulder and normal to the longitudinalaxis of said one end of the tube portion.

5. The device of claim 4 wherein said heel section of said pad-likeportion is adapted by its shape and position to engage the interiorfemale surfaces immediately anterior to the urethral meatus, so the sealformed about the urethral meatus i immediately around the same, whereinurine samples may be obtained substantially free of extraurethralcontamination.

References Cited The following references, cited by the Examiner, are ofrecord in the patented file of this patent or the original patent.

UNITED STATES PATENTS 70,087 10/ l 867 Hadfield 128300 268,555 12/1882Simpson 4-110 1,510,973 lO/l924 Behan 4--l10 2,382,276 8/1945 Wells 4110 2,490,969 12/1949 Kinyon l28295 3,122,139 2/1964 Jones 128-2753,259,920 7/1966 Voller 4-110 RICHARD A. GAUDET, Primary Examiner K. L.HOWELL, Assistant Examiner US. Cl. X.R. 4-110; 128-295

